Nobio Clinical Study - Demineralization Prevention With a New Antibacterial Restorative Composite

NCT04059250 | Completed Results FDA Device

• 1 other identifier: P0535966
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Nobio has developed dental restorative materials with long term antibacterial properties in order to fight recurrent decay/caries around restorations. These composites with incorporated non-leaching antibacterial agents might overcome the vicious circle of newly developed cavities around freshly placed fillings. The investigators will ask lower partial denture wearers to allow them to place a "gap model" with the Nobio-composite and enamel slab in one denture flange. In the other denture flange a gap model with a standard composite will be placed as control. In the laboratory the investigators will test with established methods for demineralization/caries prevention in the test and control enamel slabs, respectively.

Conditions

Dental Caries; Denture, Partial, Removable

Keywords

composite bactericidal; caries prevention

Outcome Measures

Primary Outcomes (1)

• Mineral Loss ΔZ

  The mineral loss is determined in the laboratory using cross-sectional microhardness testings of the enamel after the 4-weeks wearing period of the gap-model. The overall relative mineral loss, ΔZ, for each sample is calculated by creating a hardness profile curve by plotting normalized volume percent mineral against distance from the outer enamel surface. The area under the curve that represents ΔZ (µm \* vol % mineral) is calculated using Simpson's integration rule.

  mineral loss ΔZ is determined after the 4 week wearing period

Study Arms (2)

Nobio flange

EXPERIMENTAL

On the Nobio flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it the Nobio composite.

Device: Nobio composite

Traditional composite flange

PLACEBO COMPARATOR

On the traditional composite flange side of the lower partial denture the gap model will include a double sterilized piece of human enamel, a small gap, and next to it a traditional composite.

Device: traditional composite

Interventions

Nobio composite DEVICE

Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers

Nobio flange

traditional composite DEVICE

traditional composite which has no bactericidal activities

Traditional composite flange

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged between 18 and 80 years,
• have at least six natural teeth remaining and have a recent history of dental caries
• wearing lower partial denture (with replaced teeth on both sides of the mouth)
• willing to wear their denture during the night
• are in good health, of either gender
• are in good current oral health with no active caries or periodontal disease (but with a history of caries)
• have an understanding of the study
• have saliva flow within the normal range (stimulated saliva flow rate of greater than 0.7 ml/minute)
• no antibiotics for the last three months
• willing to comply with all study procedures and protocols,
• residing in San Francisco or other nearby locales with community water fluoridation (to eliminate water fluoridation as a potential confounding variable)
• able to give written consent themselves
• must be able to read and understand English
• willing to sign the "Authorization for Release of Personal Health Information and Use of Personally Unidentified Study Data for Research" form; data will only be used for research

You may not qualify if:

• subjects who have less than 6 natural teeth remaining
• subjects who have used a 5,000 ppm fluoride toothpaste in the last 6 months
• subjects who have used Chlorhexidine or any other antimicrobials (cetylpyridinium etc.) in the last 6 months
• show evidence of extremely poor oral hygiene
• subjects suffering from systemic diseases, significant past or medical history with conditions that may affect oral health or oral flora (i.e. diabetes, HIV, heart conditions that require antibiotic prophylaxis)
• taking medications that may affect the oral flora or salivary flow (e.g. antibiotic use in the past three months, drugs associated with dry mouth / xerostomia)
• other conditions that may decrease the likelihood of adhering to study protocol
• in-office fluoride treatment within the last three months
• subjects who will leave the area and are unable to complete the study

Sponsors & Collaborators

• University of California, San Francisco: lead
• Nobio Ltd.: collaborator

Study Sites (1)

UCSF School of Dentistry, Preventive and Restorative Dental Sciences

San Francisco, California, 94143, United States

Location

Related Publications (15)

• Clasen AB, Ogaard B. Experimental intra-oral caries models in fluoride research. Acta Odontol Scand. 1999 Dec;57(6):334-41. doi: 10.1080/000163599428580.

  PMID: 10777137 BACKGROUND

• Zero DT. In situ caries models. Adv Dent Res. 1995 Nov;9(3):214-30; discussion 231-4. doi: 10.1177/08959374950090030501.

  PMID: 8615944 BACKGROUND

• Gorton J, Featherstone JD. In vivo inhibition of demineralization around orthodontic brackets. Am J Orthod Dentofacial Orthop. 2003 Jan;123(1):10-4. doi: 10.1067/mod.2003.47.

  PMID: 12532056 BACKGROUND

• Maupome G, Sheiham A. Criteria for restoration replacement and restoration life-span estimates in an educational environment. J Oral Rehabil. 1998 Dec;25(12):896-901. doi: 10.1046/j.1365-2842.1998.00328.x.

  PMID: 9888223 BACKGROUND

• Kidd EA. Diagnosis of secondary caries. J Dent Educ. 2001 Oct;65(10):997-1000.

  PMID: 11700003 BACKGROUND

• Hals E, Nernaes A. Histopathology of in vitro caries developing around silver amalgam fillings. Caries Res. 1971;5(1):58-77. doi: 10.1159/000259733. No abstract available.

  PMID: 5277150 BACKGROUND

• Kuper NK, Montagner AF, van de Sande FH, Bronkhorst EM, Opdam NJ, Huysmans MC. Secondary Caries Development in in situ Gaps next to Composite and Amalgam. Caries Res. 2015;49(5):557-63. doi: 10.1159/000438728. Epub 2015 Sep 26.

  PMID: 26407050 BACKGROUND

• Hollanders ACC, Kuper NK, Maske TT, Huysmans MDNJM. Secondary Caries in situ Models: A Systematic Review. Caries Res. 2018;52(6):454-462. doi: 10.1159/000487200. Epub 2018 Apr 5.

  PMID: 29621757 BACKGROUND

• Benelli EM, Serra MC, Rodrigues AL Jr, Cury JA. In situ anticariogenic potential of glass ionomer cement. Caries Res. 1993;27(4):280-4. doi: 10.1159/000261551.

  PMID: 8402802 BACKGROUND

• Dijkman GE, Arends J. Secondary caries in situ around fluoride-releasing light-curing composites: a quantitative model investigation on four materials with a fluoride content between 0 and 26 vol%. Caries Res. 1992;26(5):351-7. doi: 10.1159/000261467.

  PMID: 1468099 BACKGROUND

• Beyth N, Yudovin-Farber I, Bahir R, Domb AJ, Weiss EI. Antibacterial activity of dental composites containing quaternary ammonium polyethylenimine nanoparticles against Streptococcus mutans. Biomaterials. 2006 Jul;27(21):3995-4002. doi: 10.1016/j.biomaterials.2006.03.003. Epub 2006 Mar 27.

  PMID: 16564083 BACKGROUND

• Beyth N, Houri-Haddad Y, Baraness-Hadar L, Yudovin-Farber I, Domb AJ, Weiss EI. Surface antimicrobial activity and biocompatibility of incorporated polyethylenimine nanoparticles. Biomaterials. 2008 Nov;29(31):4157-63. doi: 10.1016/j.biomaterials.2008.07.003. Epub 2008 Aug 3.

  PMID: 18678404 BACKGROUND

• Beyth N, Yudovin-Fearber I, Domb AJ, Weiss EI. Long-term antibacterial surface properties of composite resin incorporating polyethyleneimine nanoparticles. Quintessence Int. 2010 Nov-Dec;41(10):827-35.

  PMID: 20927419 BACKGROUND

• Chatzistavrou X, Velamakanni S, DiRenzo K, Lefkelidou A, Fenno JC, Kasuga T, Boccaccini AR, Papagerakis P. Designing dental composites with bioactive and bactericidal properties. Mater Sci Eng C Mater Biol Appl. 2015;52:267-72. doi: 10.1016/j.msec.2015.03.062. Epub 2015 Mar 28.

  PMID: 25953567 BACKGROUND

• Rechmann P, Le CQ, Chaffee BW, Rechmann BMT. Demineralization prevention with a new antibacterial restorative composite containing QASi nanoparticles: an in situ study. Clin Oral Investig. 2021 Sep;25(9):5293-5305. doi: 10.1007/s00784-021-03837-4. Epub 2021 Feb 19.

  PMID: 33608748 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Peter Rechmann
• Organization: University of California San Francisco

Peter.Rechmann@ucsf.edu

4155143225

Study Officials

• Peter Rechmann

  UCSF - School of Dentistry - Preventive and Restorative Dental Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Subjects are not aware, which side of the denture will harbor the gap model with the Nobio composite and which side harbors the traditional composite. Laboratory microhardness measurements will be conducted while keeping the operator blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: In-situ testing using a gap model inside the two flanges of a removable partial denture

Study Record Dates

• First Submitted: August 14, 2019
• First Posted: August 16, 2019
• Study Start: May 28, 2019
• Primary Completion: March 10, 2020
• Study Completion: March 10, 2020
• Last Updated: March 12, 2021
• Results First Posted: March 12, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)